Induced; BirthLINONCT04746248
Outpatient Labor Induction Using Oral Misoprostol in Norway
A study testing Outpatient labor induction and Inpatient labor induction in people with Induced; Birth and Labor, Induced, run by Oslo Metropolitan University at 2 sites in Norway.
Trial summary
The rate of labor induction has been steadily increasing over the last years, both worldwide and in Norway. Norwegian women are hospitalized when prostaglandins are used to induce labor. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Induced; Birth, Labor, Induced
- What is being tested?
- Outpatient labor induction and Inpatient labor induction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesNorway
- Study dates
- 25 Mar 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Healthy nulliparous women
- A single, healthy fetus in cephalic presentation at gestational age of 37 weeks or more
- Normal pregnancy
- The woman can read and communicate in Norwegian
- No cognitive barriers
- BMI 15,5-39,9
- Reside within one hour from the hospital
- Indication for labor induction is post term pregnancy, uncomplicated pre labor rupture of membranes, maternal wish or other indications determined as low-risk by the attending obstetrician
Who cannot join
- Known uterine abnormality or previous uterine surgery
- Major maternal medical illness requiring monitoring of mother or fetus in early labor
- Maternal infection
- Pregnancy complications such as preeclampsia, poorly controlled hypertension or medically treated diabetes mellitus
- Active vaginal bleeding characterized as more than bloody show
- Smoking
Show all 10Show fewer
- Non-reassuring cardiotocography or reduced fetal movement
- Fetal growth EFW < 10th percentile or >90th percentile
- Poly- or oligohydramnios
- Known abnormalities in the placenta or umbilical cord
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Vestre Viken Health Trust, Drammen Hospital
Drammen
Oslo University Hospital
Oslo
About this study
Official title: The LINO Study - Labor Induction Inpatient and Outpatent: A Pilot- and Feasibility Study of Low-risk Nulliparious Women Using 25 mcg Oral Misoprostol for Labor Induction in an Inpatient and Outpatent Setting in Norway.
The rate of labor induction has been steadily increasing over the last years, both worldwide and in Norway. Norwegian women are hospitalized when prostaglandins are used to induce labor. In Denmark, a neighboring country to Norway, women have been offered outpatient induction of labor using oral misoprostol for several years.
The overall aim of this study is to investigate if outpatient induction of labor is beneficial in a Norwegian setting. This includes:
Read more
- To investigate the clinical outcomes and feasibility of inducing in an outpatient setting compared to an inpatient setting in Norway
- To explore low-risk nulliparous women's experiences of labor induction in inpatient and outpatient settings.
This is a non-randomized prospective pilot- and feasibility study, collecting data from electronical records. In addition, the study participants are invited to write a diary during the labor induction process and a questionnaire six weeks postpartum. Eligible patients include low-risk nulliparous women induced with low-dose oral misoprostol.
Read the detailed description
The labor induction rate in Norway has increased from 10,5 % in 2000 to 26,1 % in 2019. This represents an important shift in the obstetric care, making labor induction one of the most common obstetrical interventions. The increase alters the population being induced, as it now includes more low-risk births compared to 20 years ago. The low risk labor inductions might not require the same repeated cardiotocography and inpatient care before onset of active labor as complicated pregnancies.
In 2017, a 25 μg misoprostol tablet for oral administration was approved for labor induction in the Nordic countries. Oral administration is user friendly, and low-dose orally administrated misoprostol is considered to have a favorable safety profile compared to many other induction methods, with low risk of hyperstimulation.
Despite the widespread knowledge of the importance of women´s labor experience for her future health, this aspect is rarely thoroughly explored in the vast number of studies on labor induction. For outpatient labor induction to work, it must be an alternative women find beneficial, as well as clinicians and the health care system.
Aim
The overall aim of this study is to investigate if outpatient induction of labor is beneficial in a Norwegian setting. This includes:
Study A. To investigate the clinical outcomes and feasibility of inducing in an outpatient setting compared to an inpatient setting in Norway Study B. To explore low-risk nulliparous women's experiences of labor induction in inpatient and outpatient settings.
Design and methods
Study A is a prospective non-randomized multicenter pilot- and feasibility study. Data are collected from the patient's electronical records. Study B is a mixed methods cross-sectional diary study, collecting data from the participants diaries and questionnaire and their electronical records. Both studies include the same participants.
In both the inpatient and outpatient regime, the women are induced with 25 μg misoprostol tablets administrated orally every two hours. Some of the women will be induced using a balloon catheter before misoprostol. In the inpatient regime, cardiotocography (CTG) will be performed according to standard protocol; every 4-6 hours or on indication. In the outpatient protocol, a CTG will be carried out before and after the administration of the first misoprostol. If the CTG is normal and the woman has no contractions, the woman can go home, provided a normal ultrasound scan from the last three weeks. An appointment will be set up no later than 24 hours later for a new CTG and assessment of the induction process and the health of the woman and fetus. If the woman goes home after this consultation, she will return no later than 24 hours later for inpatient labor induction if the labor does not start.
Women choosing the outpatient protocol will receive oral and written information about what they should be aware of and when to contact the maternity ward. They are welcome to contact the maternity ward at any time to seek advice from a midwife with experience in labor induction.
- Conditions
- Induced; Birth, Labor, Induced
- Being tested
- Outpatient labor induction, Inpatient labor induction
- Keywords
- Labor induction, Induced birth, Outpatient, Oral misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outpatient labor inductionOther
The participants stay at home during til labor induction process and are admitted to hospital at the onset of labor or if a complication occur. Outpatient consultations once a day.
Inpatient labor inductionOther
The participants are induced following standard inpatient care
| Study group | Role | What they receive |
|---|---|---|
| Baseline | No intervention | The baseline arm includes participants from before the implementation of the outpatient regime. All participants are induced according to the standard inpatient protocol. |
| Women choosing to stay at the hospital | Active comparator | Include women who choose to stay at the hospital after implementing an outpatient alternative. Receives: Other: Inpatient labor induction |
| Women choosing to go home | Experimental | Include women who choose the outpatient regime. Receives: Other: Outpatient labor induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of eligible women selecting outpatient labor induction
Measured: up to 18 months
Fetal metabolic acidosis
The proportion of fetal metabolic acidosis
Measured: From delivery and within two hours postpartum
Deliveries outside the hospital
The proportion of deliveries outside the hospital in the outpatient versus inpatient induction group
Measured: At time of delivery
Secondary outcomes (22)
Delivery mode
Mutually exclusive categories, either spontaneous vaginal birth, either instrumental vaginal birth, either operative delivery by cesarean section
Measured: At the time of delivery
Indications for operative delivery
Indications for cesarean delivery or operative vaginal delivery
Measured: At the time of delivery
Uterine rupture
Measured: During labor induction or birth
Maternal admission to ICU or maternal death
Measured: From start of induction through discharge, normally within 2-4 days after delivery
Maternal hemorrhage (in ml)
Measured: During birth and until two hours after delivery
Chorioamnionitis
Number of participants with clinical chorioamnionitis
Measured: During birth and until two hours after delivery
Perineal injury
Perineal third or forth degree lacerations and epiosotomy
Measured: At the time of delivery
Perinatal death
Measured: From start of induction until 1 week after delivery
Need for neonatal resuscitation after delivery
Measured: Within two hours after delivery
Uterine tachysystole
Measured: From start of induction until delivery
Admission to NICU due to birth related issues
Measured: From delivery until discharge, usually 2-4 days after delivery, maximum of 1 week postpartum
Apgar score
Score 0 to 10 where 10 is highest score indicating most vital neonate
Measured: 1, 5 and 10 minutes after delivery
Umbilical cord pH and pCO2
Measured: Immediately after delivery
Presence of meconium in amniotic fluid
Measured: From start of induction until delivery
Duration of the stages during induction and birth
Time from start of medication to start of active labor, labor duration, duration of hospital stay
Measured: From start of induction until transfer top postpartum ward
Contact with the hospital during the labor induction process
Counting number of contacts adding up to a total
Measured: From start of induction until hospital admission
Misoprostol administration
Total misoprostol dose, delay of medicament administration
Measured: From start of induction until start of active labor
Need for other interventions to induce or augment labor
Measured: From start of induction until start of active labor
The experience of labor induction
The Experiences of Induction Tool (EXIT), a validated instrument to measure the experiences of labor induction Minimum score per item is 1, maximum is 5, the higher the score the more positive the experience.
Measured: 6-8 weeks postpartum
The experience of childbirth
The Childbirth Experience Questionnaire (CEQ), a validated instrument to measure the experience of childbirth, 4 domains, mean for each domain will be calculated and compared, the higher mean per domain the more positive the birth experience, lowest mean per domain is 1 highest is 4.
Measured: 6-8 weeks postpartum
Postnatal depression
The Edinburgh Postnatal Depression Scale-short version (EPDS-5), Minimum score 0, maximum score 15, cut-off 7 or more The higher the score the more symptoms of depression
Measured: 6-8 weeks postpartum
The Early Labor Experience
Swedish Early Labor Questionnaire for primiparous women (SWE-ELEQ-PP), a validated instrument to measure measure the experience of early labor, 22 items mean score is calculated, higher score is better experience, minimum score per items is 1 maximum is 5
Measured: From start of induction until delivery and 6-8 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start25 Mar 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Induced; BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital, Vestre Viken Hospital Trust
- Responsible party
- Principal investigator, Mirjam Lukasse, Oslo Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04746248
- Sponsor's protocol ID
- 158844
- Acronym
- LINO
- Status last verified
- Mar 2023
- First submitted
- 25 Jan 2021
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marsdal KE, Sorbye IK, Bernitz S, Adan N, Grodal EB, Jacobsen AF, Lukasse M. Clinical outcomes and feasibility of implementing outpatient labor induction with misoprostol: A prospective cohort study. Acta Obstet Gynecol Scand. 2025 Apr;104(4):647-657. doi: 10.1111/aogs.15029. Epub 2025 Jan 29.
PubMed 39878306
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The LINO Study - Labor Induction Inpatient and Outpatent: A Pilot- and Feasibility Study of Low-risk Nulliparious Women Using 25 mcg Oral Misoprostol for Labor Induction in an Inpatient and Outpatent Setting in Norway.
- ClinicalTrials.gov ID
- NCT04746248
- Acronym / sponsor ID
- LINO / 158844
- Conditions
- Induced; Birth, Labor, Induced
- Keywords
- Labor induction, Induced birth, Outpatient, Oral misoprostol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Collaborators
- Oslo University Hospital, Vestre Viken Hospital Trust
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 9 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The rate of labor induction has been steadily increasing over the last years, both worldwide and in Norway. Norwegian women are hospitalized when prostaglandins are used to induce labor. In Denmark, a neighboring country to Norway, women have been offered outpatient induction of labor using oral misoprostol for several years.
The overall aim of this study is to investigate if outpatient induction of labor is beneficial in a Norwegian setting. This includes:
- To investigate the clinical outcomes and feasibility of inducing in an outpatient setting compared to an inpatient setting in Norway
- To explore low-risk nulliparous women's experiences of labor induction in inpatient and outpatient settings.
This is a non-randomized prospective pilot- and feasibility study, collecting data from electronical records. In addition, the study participants are invited to write a diary during the labor induction process and a questionnaire six weeks postpartum. Eligible patients include low-risk nulliparous women induced with low-dose oral misoprostol.
Detailed description
The labor induction rate in Norway has increased from 10,5 % in 2000 to 26,1 % in 2019. This represents an important shift in the obstetric care, making labor induction one of the most common obstetrical interventions. The increase alters the population being induced, as it now includes more low-risk births compared to 20 years ago. The low risk labor inductions might not require the same repeated cardiotocography and inpatient care before onset of active labor as complicated pregnancies.
In 2017, a 25 μg misoprostol tablet for oral administration was approved for labor induction in the Nordic countries. Oral administration is user friendly, and low-dose orally administrated misoprostol is considered to have a favorable safety profile compared to many other induction methods, with low risk of hyperstimulation.
Despite the widespread knowledge of the importance of women´s labor experience for her future health, this aspect is rarely thoroughly explored in the vast number of studies on labor induction. For outpatient labor induction to work, it must be an alternative women find beneficial, as well as clinicians and the health care system.
Aim
The overall aim of this study is to investigate if outpatient induction of labor is beneficial in a Norwegian setting. This includes:
Study A. To investigate the clinical outcomes and feasibility of inducing in an outpatient setting compared to an inpatient setting in Norway Study B. To explore low-risk nulliparous women's experiences of labor induction in inpatient and outpatient settings.
Design and methods
Study A is a prospective non-randomized multicenter pilot- and feasibility study. Data are collected from the patient's electronical records. Study B is a mixed methods cross-sectional diary study, collecting data from the participants diaries and questionnaire and their electronical records. Both studies include the same participants.
In both the inpatient and outpatient regime, the women are induced with 25 μg misoprostol tablets administrated orally every two hours. Some of the women will be induced using a balloon catheter before misoprostol. In the inpatient regime, cardiotocography (CTG) will be performed according to standard protocol; every 4-6 hours or on indication. In the outpatient protocol, a CTG will be carried out before and after the administration of the first misoprostol. If the CTG is normal and the woman has no contractions, the woman can go home, provided a normal ultrasound scan from the last three weeks. An appointment will be set up no later than 24 hours later for a new CTG and assessment of the induction process and the health of the woman and fetus. If the woman goes home after this consultation, she will return no later than 24 hours later for inpatient labor induction if the labor does not start.
Women choosing the outpatient protocol will receive oral and written information about what they should be aware of and when to contact the maternity ward. They are welcome to contact the maternity ward at any time to seek advice from a midwife with experience in labor induction.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Baseline | No intervention | –The baseline arm includes participants from before the implementation of the outpatient regime. All participants are induced according to the standard inpatient protocol. |
| Women choosing to stay at the hospital | Active comparator | Other: Inpatient labor inductionInclude women who choose to stay at the hospital after implementing an outpatient alternative. |
| Women choosing to go home | Experimental | Other: Outpatient labor inductionInclude women who choose the outpatient regime. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy nulliparous women
- A single, healthy fetus in cephalic presentation at gestational age of 37 weeks or more
- Normal pregnancy
- The woman can read and communicate in Norwegian
- No cognitive barriers
Key exclusion criteria (10 listed)
- Known uterine abnormality or previous uterine surgery
- Major maternal medical illness requiring monitoring of mother or fetus in early labor
- Maternal infection
- Pregnancy complications such as preeclampsia, poorly controlled hypertension or medically treated diabetes mellitus
- Active vaginal bleeding characterized as more than bloody show
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Outpatient labor inductionThe participants stay at home during til labor induction process and are admitted to hospital at the onset of labor or if a complication occur. Outpatient consultations once a day. | Other | Women choosing to go home |
| Inpatient labor inductionThe participants are induced following standard inpatient care | Other | Women choosing to stay at the hospital |
Primary outcome
The proportion of eligible women selecting outpatient labor induction
Time frame: up to 18 months
Fetal metabolic acidosis
Time frame: From delivery and within two hours postpartum
The proportion of fetal metabolic acidosis
Deliveries outside the hospital
Time frame: At time of delivery
The proportion of deliveries outside the hospital in the outpatient versus inpatient induction group
22 secondary outcomes
Delivery mode
Time frame: At the time of delivery
Indications for operative delivery
Time frame: At the time of delivery
Uterine rupture
Time frame: During labor induction or birth
Maternal admission to ICU or maternal death
Time frame: From start of induction through discharge, normally within 2-4 days after delivery
Maternal hemorrhage (in ml)
Time frame: During birth and until two hours after delivery
Chorioamnionitis
Time frame: During birth and until two hours after delivery
Perineal injury
Time frame: At the time of delivery
Perinatal death
Time frame: From start of induction until 1 week after delivery
Need for neonatal resuscitation after delivery
Time frame: Within two hours after delivery
Uterine tachysystole
Time frame: From start of induction until delivery
Admission to NICU due to birth related issues
Time frame: From delivery until discharge, usually 2-4 days after delivery, maximum of 1 week postpartum
Apgar score
Time frame: 1, 5 and 10 minutes after delivery
Umbilical cord pH and pCO2
Time frame: Immediately after delivery
Presence of meconium in amniotic fluid
Time frame: From start of induction until delivery
Duration of the stages during induction and birth
Time frame: From start of induction until transfer top postpartum ward
Contact with the hospital during the labor induction process
Time frame: From start of induction until hospital admission
Misoprostol administration
Time frame: From start of induction until start of active labor
Need for other interventions to induce or augment labor
Time frame: From start of induction until start of active labor
The experience of labor induction
Time frame: 6-8 weeks postpartum
The experience of childbirth
Time frame: 6-8 weeks postpartum
Postnatal depression
Time frame: 6-8 weeks postpartum
The Early Labor Experience
Time frame: From start of induction until delivery and 6-8 weeks postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Derived from this study: PubMed 39878306Marsdal KE, Sorbye IK, Bernitz S, Adan N, Grodal EB, Jacobsen AF, Lukasse M. Clinical outcomes and feasibility of implementing outpatient labor induction with misoprostol: A prospective cohort study. Acta Obstet Gynecol Scand. 2025 Apr;104(4):647-657. doi: 10.1111/aogs.15029. Epub 2025 Jan 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outpatient labor induction and Inpatient labor induction in people with Induced; Birth and Labor, Induced, run by Oslo Metropolitan University at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of eligible women selecting outpatient labor induction (time frame: up to 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04746248, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.